High Dose Aflibercept in Diabetic Macular Edema in Patients With Previous Vitrectomy
Eligible age
21+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
Patients with diabetic macular edema (DME) sometimes must undergo vitrectomy surgery (PPV) for diabetic and non-diabetic related issues. Patients may have improved DME with anti-VEGF therapy and ranibizumab has been found to reduce central macular thickness (CMT) with anti-VEGF therapy following vitrectomy. Those patients still require intravitreal injections but the pharmacokinetics of a vitrectomized eye are different than those eyes that have not undergone vitrectomy. The clearance of protein molecules is quicker in vitrectomized eyes so these patients may be more refractory to standard of care anti-VEGF therapy. In rabbit models, the half-life of both bevacizumab and ranibizumab were reduced by a factor 1.8 and 1.3, respectively, after pars plana vitrectomy. In a study examining intravitreal triamcinolone acetonide in human eyes, the half-life was found to be 18.6 days in non-vitrectomized eyes and 3.2 days in vitrectomized eyes, but there was considerable intrasubject variation. Patients with various disease states, including neovascular age-related macular degeneration (nAMD) have been managed with monthly anti-VEGF therapy successfully after vitrectomy surgery. Another study performed by the DRCR net showed that patients with DME treated with anti-VEGF are not affected in the long term if they had had a previous vitrectomy. High dose aflibercept may improve anatomic and visual outcomes in this patient population. Also, high dose aflibercept may allow for longer treatment intervals in these vitrectomized eyes.
Sponsor: Retina Consultants of Orange County
You may qualify if…
- ✓ A patient must meet the following criteria at both the screening and randomization visits (except where indicated) to be eligible for inclusion in the study:
- ✓ 1. Men or women ≥18 years of age with type 1 or type 2 diabetes mellitus
- ✓ 2. DME with central involvement in the study eye with CRT ≥320 μm on Spectralis.
- ✓ 3. BCVA early treatment diabetic retinopathy study (ETDRS) letter score of 84 to 20 (approximate Snellen equivalent of 20/25 to 20/400) in the study eye with decreased vision determined to be primarily the result of DME
- ✓ 4. Willing and able to comply with clinic visits and study-related procedures
- ✓ 5. Provide informed consent signed by study patient or legally acceptable representative
- ✓ 6. Have a previous history of vitrectomy surgery.
You may not qualify if…
- ✕ A patient who meets any of the following criteria at either the screening or randomization visits will be excluded from the study:
- ✕ 1. Evidence of macular edema due to any cause other than diabetes mellitus in either eye
- ✕ 2. Prior intravitreal investigational agents in the study eye (gene therapy, etc.) at any time
- ✕ 3. IOP ≥28 mmHg in the study eye
- ✕ 4. History of glaucoma filtration surgery in the past
- ✕ 5. Evidence of infectious blepharitis, keratitis, scleritis , or conjunctivitis in either eye within 4 weeks (28 days) of the screening visit.
- ✕ 6. Any intraocular inflammation/infection in either eye within 6 weeks (42 days) of the screening visit.
- ✕ 7. History of idiopathic or autoimmune uveitis in the study eye
Where it's recruiting
Fullerton
Source: ClinicalTrials.gov · NCT06662994 · last updated 2025-07-10